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Gelnique

Generic name: oxybutynin hydrochloride
Treatment for: Overactive Bladder

Update: Gelnique Now FDA Approved - January 27, 2009

Oxybutynin Topical Gel NDA Accepted for Filing

Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing byFDA for the Treatment of Overactive Bladder

CORONA, Calif., May 28, 2008 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that its New Drug Application (NDA) for oxybutynin chloride topical gel (OTG), has been accepted for filing by the U.S. Food and Drug Administration (FDA). Watson is seeking marketing approval of this novel transdermal gel of oxybutynin hydrochloride for the treatment of overactive bladder (OAB).

OTG is a clear, rapid-drying gel designed to produce consistent oxybutynin concentrations over a 24-hour period. By administering oxybutynin through the skin, OTG avoids first pass metabolism and the resultant high metabolite levels seen with oral oxybutynin dosing. A nickel-sized, one-gram unit dose of OTG, applied once daily, delivers about 4mg oxybutynin each day.

"Innovative products like OTG represent Watson's ongoing focus on developing effective, safe and convenient treatments that help to improve patients' lives," said Ed Heimers, Jr., Executive Vice President and President of Watson's Brand Division. "We believe this new formulation of oxybutynin signifies an important advancement in treatment options for OAB as it offers the benefits of transdermal therapy with excellent skin tolerability."

The NDA filing for OTG is based on data from a Phase 3 randomized, double-blind, placebo-controlled study involving 789 patients with OAB. In the 12-week study, patients treated with OTG once daily experienced a highly significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per day, a decrease in urinary frequency and an increase in the average urine volume per void. Significant improvements relative to placebo in quality of life, as measured by the Incontinence Impact Questionnaire (IIQ) and the incontinent specific domains of the King's Health Questionnaire (KHQ), were also observed in the patients using the OTG.

OTG was well tolerated in the study and there were no serious adverse events related to treatment. Dry mouth and application site pruritus were the only treatment-related side effects reported in more than 2% of participants.

"Watson is excited to be expanding the portfolio of innovative treatments it offers physicians and their patients," Heimers said. "Through developing novel therapies such as the OTG, we can continue to be the partner of choice to help the millions of people suffering from urological conditions manage their symptoms and enjoy their daily lives."

About Overactive Bladder (OAB)

OAB is common condition marked by excessive feelings of urgency, with or without urge incontinence, and usually includes frequency of urination and nocturia (waking up at least once during the night to urinate). It affects as many as 33 million men and women in the U.S. -- more than diabetes or asthma. (1)(2)(3) OAB can force a person to limit his or her participation in physical and social activities, leaving sufferers feeling frustrated, anxious, embarrassed and sleep deprived.

About Oxybutynin Chloride Topical Gel (OTG)

OTG is a clear, odorless, ethanolic gel that provides for delivery of oxybutynin hydrochloride in a non-patch transdermal form. OTG is under development for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.

The mission of Watson Urology is to offer products and services that improve the quality of patients' lives, and satisfy the needs of physicians who specialize in the diagnosis, management, and treatment of urological disorders. By advancing education and support for urological diseases, we are working toward creating the differences that make life more livable.

In the U.S., the Watson portfolio includes: Oxytrol(R); TRELSTAR(R) LA; TRELSTAR(R) Depot; Androderm(R); AndroGel(R), under a co-promotion agreement with Solvay Pharmaceuticals, Inc., and ProQuin(R) XR, under a co-promotion agreement with Depomed, Inc. The Watson portfolio also includes a number of products under development including: silodosin, a product under development for the treatment of benign prostatic hyperplasia; a six-month formulation of TRELSTAR(R) (triptorelin pamoate for injectable suspension), under development for the treatment of advanced prostate cancer; and OTG, under development for overactive bladder.

Forward-Looking Statement

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; whether the results of clinical trials for oxybutynin chloride topical gel and other information will be sufficient to support approval by FDA and other regulatory authorities; delays regarding the regulatory approval process, including the timing and scope of approval received, if any; market acceptance and continued demand for Watson's products, including oxybutynin chloride topical gel, if approved; our ability to successfully defend and/or enforce our patents and other intellectual property rights against third parties; patents and other intellectual property rights held by competitors and other third parties; successful compliance with FDA and other governmental regulations applicable to Watson's products and/or business; the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2007.

    (1) Rovner ES, Wein AJ.  Incidence and Prevalence of Overactive Bladder.

        Current Urology Reports. 2002;3:434-438.

    (2) Estimated to be 20.8 million Americans according to: Centers for

        Disease Control and Prevention. National diabetes fact sheet: general

        information and national estimates on diabetes in the United States,

        2005. Atlanta, GA: U.S. Department of Health and Human Services,

        Centers for Disease Control and Prevention, 2005. 

    (3) Estimated to be 20 million Americans according to: Moorman JE, Rudd

        RA, Johnson CA, et al. National Surveillance for Asthma -- United

        States, 1980 -- 2004. MMWR. October 19, 2007;56(SS08); 1-14;18-54.

Posted: May 2008

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